Chain Drug Review, March 16th, 2020

RX News Study Will Assess If Antibody Can Stop or Slow Alzheimers ers Therapeutic Research Institute ATRI in San Diego and Reisa Sperling and Keith Johnson from Brigham and Womens Hospital and Massachusetts General Hospital Harvard Medical School in partnership with Eisai Alzheimers disease is an urgent problem with almost 6 million Americans plus their loved ones affected by this illness said Dr Laura Mosqueda dean of the Keck School and professor of geriatrics and family medicine ATRIs expertise in clinical trial design and implementation and data analysis along with a strong commitment to sharing data to advance the field makes me confident USC will make significant progress in identifying a treatment for this terrible disease There is no cure for Alzheimers and the problem is growing as more mine the impact of amyloid removal on cognitive decline and biological markers of Alzheimers disease when administered to people who do not yet have substantial irreversible damage from Alzheimers BAN2401 is a humanized monoclonal antibody comprised of aggregated forms of Aβ including protofibrils as an antigen It is based on the research of cases of Swedish familial Alzheimers disease with Arctic mutation which concluded abnormal accumulation of Aβ protofibrils may be a cause of Alzheimers disease onset A previous phase 2 study showed that BAN2401 removes brain amyloid and possibly slows cognitive decline Investigators hope that administration of BAN2401 very early in the disease before symptoms occur may significantly slow disease progression While BAN2401 is being studied in other clinical trials the USC study will incorporate the exploration of biomarkers using positron emission tomography PET scans and cerebrospinal fluid measures LOS ANGELES The Keck School of Medicine of the University of Southern California is launching a large clinical study to determine whether a man made antibody would slow or stop the progression of Alzheimers disease by targeting memory robbing plaques in the earliest stages of the illness A public private partnership the AHEAD 3 45 Study will be conducted with funding from the National Institute on Aging part of the National Institutes of Health NIH and pharmaceutical company Eisai Inc the U S subsidiary of Japan based Eisai Co The trial will be run by and as part of the NIH funded Alzheimers Clinical Trial Consortium ACTC The study will be led by Dr Paul Aisen director of USCs Alzheim Americans are diagnosed with the disease USC researchers project that by 2050 the number of Americans diagnosed with Alzheimers will have risen to nearly 14 million and the cost of their care will have tripled to 11 trillion annually Aisen is among 100 Keck Medicine researchers who study the memoryrobbing illness searching for potential therapies and analyzing its impact on the health care system plus its toll on caregivers Along with Sperling and Ronald Petersen director of the Mayo Clinic Alzheimers Disease Research Center and professor of neurology at Mayo Clinic College of Medicine and Science Aisen is co director of ACTC The drug in the study BAN2401 delivered intravenously is designed to bind to a sticky toxic protein called beta amyloid The binding neutralizes beta amyloid and helps tag it so the immune system can recognize it and clear it from the brain Many scientists believe that amyloid accumulation in the brain is the inciting event in Alzheimers disease We know that BAN2401 treatment is effective at reducing amyloid deposits in the brain as shown by the normalization of amyloid PET scans Aisen said Our study will deter For this four year study about 9000 individuals recruited from 100 sites globally will be screened to find 1400 people who are clinically normal and have intermediate or elevated levels of amyloid in their brains Researchers hope to screen the first participant by May 31 and complete enrollment in 18 to 30 months The study group will be divided into two double blind substudies named A3 and A45 Participants will be randomly assigned to receive the drug or a placebo Neither the participants nor the scientists will know who is receiving a particular treatment The A3 substudy will include 400 cognitively normal participants with intermediate levels of amyloid as determined by amyloid PET scan who are at high risk for further amyloid buildup They will get intravenous infusions of BAN2401 or a placebo every four weeks for 216 weeks The A45 substudy will include 1000 participants with little to no cognitive impairment who have elevated levels of amyloid in the brain and are at high risk for progression to mild cognitive impairment and Alzheimers dementia The study will test whether highdose BAN2401 every two weeks for 96 weeks can clear amyloid buildup and afterward whether further doses of BAN2401 could prevent plaque from reappearing Amyloid deserves the attention we have given it Aisen said Amyloid accumulation begins the disease process and it predicts progressive cognitive decline to dementia All of the known genetic causes of Alzheimers disease are tightly linked to amyloid accumulation Laura Mosqueda Paul Aisen All of the known genetic causes of Alzheimers are tightly linked to amyloid accumulation Aprecia Purdue Partner On 3D Printing of Drugs BLUE ASH Ohio Health care is poised for a potential giant leap forward thanks to the 3D printing of medications To advance the technology and science of 3D pharmaceutical printing Purdue Universitys College of Pharmacy and Aprecia Pharmaceuticals are launching a comprehensive collaboration on future 3DP pharmaceutical equipment and medications Aprecias mission is to maximize and expand its 3DP technology platform through global partnerships that will provide pharmaceutical solutions for unmet patient needs said Chris Gilmore chief executive officer of Aprecia Purdue University is an esteemed institution and we are confident that this partnership will advance our future in 3DP pharmaceutical research and development Aprecia Pharmaceuticals is the world leader in 3D pharmaceutical processes in 2015 Aprecia developed the first 3D printed medication to receive Food and Drug Administration approval According to Eric Barker dean of Purdues College of Pharmacy the agreement brings together an exchange of faculty and research scholars access to highly educated students and joint collaborations in research and discovery learning and teaching engagement and technical assistance Purdue University is committed to its investment in drug discovery and development as well as student and faculty enrichment that will continue to yield global advancement in medicine and health care Barker said As a college our mission is to prepare the next generation of leaders in pharmacy Partnering with Aprecia aligns perfectly with that mission We are excited to combine our talented students and faculty with the successful researchers at Aprecia to work together to accelerate discoveries in this emerging field Collaborating on R D teaching and technical assistance Eric Munson head of the colleges Department of Industrial and Physical Pharmacy said that the collaboration will spur the development of advanced medications Giving our faculty and students access to 3DP technology through research projects internships and joint collaborations advances our mission of educating and training students through scientific discovery and development Munson said Incorporating the latest technological developments like 3DP into our program is key to producing the best workforce in pharmaceutical formulation and manufacturing Racing for Coronavirus Cure the drug discovery and development process at every stage positioning Regeneron to respond quickly and effectively to new pathogens We are eager to expand our productive collaboration with BARDA and are already working hard to address the novel coronavirus that is causing worldwide concern Emerging infectious diseases can present serious threats to our nations health security said Rick Bright deputy assistant secretary for preparedness and response and director of BARDA Working as public private partners like we have with Regeneron since 2014 we can move rapidly to respond to new global health threats Biotechnology company Novavax Inc announced progress in its efforts to develop a coronavirus vaccine The company has produced and is assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing which is expected to begin by the end of spring Novavax created the COVID 19 vaccine candidates using its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike S protein The company expects to utilize its proprietary Matrix M adjuvant with its COVID 19 vaccine candidate to enhance immune responses Our previous experience working with other corona viruses including both MERS and SARS allowed us to mobilize quickly against COVID 19 and successfully complete the critical preliminary steps to engineer viable vaccine candidates said president and CEO Stanley Erck Now that the protein has been expressed stably in our baculovirus system we aim to identify the optimal candidate and scale up production of sufficient vaccine for preliminary clinical trials We are now well positioned to advance the COVID 19 vaccine candidate to Phase I clinical testing in May or June GlaxoSmithKline PLC and Clover Biopharmaceuticals a China based global clinical stage biotechnology company have entered into a research collaboration for GSKs protein based vaccine candidate COVID 19 S Trimer GSK will provide Clover with its pandemic adjuvant system for further evaluation of S Trimer in preclinical studies Having one of the largest inhouse commercial scale cGMP current Good Manufacturing Practices biomanufacturing capabilities in China Clover could potentially rapidly scale up and produce large quantities of a new coronavirus vaccine We are proud to contribute to cutting edge research from scientists at Clover Biopharmaceuticals in China as part of our strategy to make our adjuvant technology available to selected partners who have a promising vaccine candidate against the newly emerged coronavirus said Thomas Breuer chief medical officer of GSK Vaccines The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose allowing more vaccine doses to be produced and therefore contributing to protect more people At Clover we look forward to evaluating the combination of GSKs pandemic adjuvant system and our STrimer as a vaccine candidate said Joshua Liang chief strategy officer and board director Continued from page 61 62 Chain Drug Review March 16 2020